Towards the Regulation of Digital Therapeutics

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By Dr. Stephen Schueller

Dr. Schueller is the Executive Director of PsyberGuide and an Assistant Professor of Psychological Science at the University of California, Irvine. His work focuses on increasing the accessibility and availability of mental health resources through technology. In addition to One Mind, his work has been supported by the National Institute of Mental Health, the Robert Wood Johnson Foundation, and the Jacobs Foundation. He has received Rising Star Awards from the Association for Psychological Science and the International Society for Research on Internet Interventions.

In 2017, digital therapeutics took a huge step forward in establishing their legitimacy through advancements in regulatory approvals. In September, Pear Therapeutics was granted a de novo clearance by the Federal Drug Administration (FDA) for reSET. reSET is the first software-only prescription digital therapeutic. It is intended for the treatment of substance use and has established efficacy at increasing abstinence drawn for a clinical trial comparing face-to-face counseling plus a therapeutic education system (essentially a web-based version or reSET with equivalent content) to treatment-as-usual.1 This is a promising sign that not only can digital therapeutics be effective for behavioral and mental health issues, but also that regulatory groups are taking these treatment options seriously. Pear Therapeutics is also pursuing fast-tracking through the clearance process for reSET-O, a product designed specifically for opioid use disorder, and is developing and evaluating products for schizophrenia, PTSD, and generalized anxiety disorder. In total, 51 devices ranging from apps to wearables received clearance from the FDA in 2017. The FDA also selected nine companies to participate in a Pre-cert pilot program that integrates evaluation of the digital health technology developer into the process to help account for the iterative and rapidly advancing nature of digital health products. These companies – Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorous, Roche, Samsung, Tidepool, and Verily – represent a blend of traditional developers of health products with technology companies with growing endeavors in health.

These developments represent a sea change in the way that health products are evaluated before being determined acceptable for consumers. First, it is worth noting that the approval of reSET was based on data not from the evaluation of the app itself but from the evaluation of a Therapeutic Education System (TES). The TES is a web-based program developed through the research program of Lisa Marsch based on the Community Reinforcement Approach to behavior therapy. Dr. Marsch has a long history of work in using digital therapeutics in substance use disorders with several studies showing promising efficacy work. It is likely that digital therapeutics that work on web-based platforms will likely work in app-based platforms. However, we also need to know how web-based platforms and app-based platforms differ. To what degree can we change or adapt features will maintaining the efficacy of a product. How do privacy, security, and safety concerns vary between web- and app-based platforms? For researchers, this signals that an app-based adaptation of a program is likely not viewed as different and definitely not innovative when strong evidence supports a web-based version. What additional data will be required when we move to more novel forms of digital interactions – virtual reality, augmented reality, conversational agents, and chatbots? Second, the developers of digital therapeutics are being considered as part of the approval process. This will likely speed innovation but at what point will we re-visit if these companies truly have our health at the center of their interests? Third, what will the impact of government approval and regulation have on the health app market more generally? Although the rate of development of health apps has slowed in 2017, there are still 25% more health apps available in 2017 than 2016 (with approximately 78,000 new apps added to the app stores).2 Will health apps continued to be developed at this rate and will app marketplaces make any attempt to further regulate or evaluate these apps?

As much change as we saw in 2017 there is no sign that things will slow in 2018. As mentioned previously, technology companies are becoming increasingly interested in health. Federally-funded research grants continue to heavily invest in work in digital therapeutics. The National Institute of Mental Health prioritizes the use of technology within its strategic plan and NIMH awarded 404 grants totally $445 million for technology-enhanced mental health intervention grants between 2009 and 2015. The National Institutes of Health are leveraging technology heavily for the recruitment and data collection of the All of Us Research Program. It is an exciting time for digital therapeutics and hopefully we will start to see such interventions truly move the needle in improving the health and mental health of the world.

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